TeraRecon Aorta.CT (1.1.0) automatically segments the aorta and labels 22 aortic anatomical landmarks from adult contrast CTA DICOM for trained professionals' review in standard-of-care planning; it does not alter the original images or provide a diagnosis and excludes the FDA-listed device/anatomy conditions.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
TeraRecon Aorta.CT (1.1.0) automatically segments the aorta and labels 22 aortic anatomical landmarks from adult contrast CTA DICOM for trained professionals' review in standard-of-care planning; it does not alter the original images or provide a diagnosis and excludes the FDA-listed device/anatomy conditions.
Automatic aortic segmentation and landmarking to support clinician measurements and procedure planning; the qualified professional remains responsible for interpretation and patient management.
Automatic 3D aortic lumen and wall-to-wall segmentation with 22 labeled aortic anatomical landmarks, delivered as DICOM result files viewable by DICOM-compliant systems.
The indication is for adults and excludes patients with a pre-existing aortic device, bicuspid aortic valve anomaly, aortic dissection, aortic rupture, or abdominal metallic devices. Motion, occluded vessels, lack of contrast, artifacts, or landmarks outside the field of view can prevent annotation or affect output. The device does not alter original input data and does not provide a diagnosis.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The exact submission accepts CTA DICOM and returns DICOM result files for viewing by DICOM-compliant systems; local routing, viewer behavior, identifiers, and report ingestion require site acceptance testing.
The exact submission is a containerized application that can run on off-the-shelf hardware or on a cloud platform; the reviewed sources do not establish the current site-specific hosting, storage, retention, availability, or service-level arrangement.
The reviewed exact packet and official regulatory page do not establish current scoped security controls, encryption, PHI flow, retention, access control, audit, vulnerability management, or incident response for the installed K243158 release.
Training and support
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-07
The FDA indication requires trained professionals and understanding of capabilities and limitations, but no exact-version curriculum, competency assessment, or support terms were established.
Monitoring and change control
Monitor adult CTA eligibility, contrast and field-of-view adequacy, motion or artifact-related failures, segmentation and landmark review, DICOM result delivery, failed or repeated analyses, reader overrides, downtime, updates, complaints, and exact-submission recalls.
FDA source
Exact FDA submission
Checked 2026-09-07
Buyer acceptance guidance derived from the exact FDA workflow and validation scope; it is not a claimed vendor monitoring service.
TeraRecon's current regulatory page describes Aorta.CT as automatic 3D aortic segmentation and landmarking from contrast CT angiography DICOM, with DICOM result files usable by DICOM-compliant systems and no alteration of original data or diagnosis. This is current product-family context, not exact-version performance evidence.
The exact FDA submission describes a containerized application on off-the-shelf hardware or a cloud platform and DICOM result output; confirm container runtime, compute, storage, routing, and upgrade behavior during local qualification.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Evidence summary
K243158 FDA evidence is a retrospective manufacturer-submitted regulatory validation. Segmentation results come from 170 adult aortic CTA studies; landmarking required 29 supplemental studies after field-of-view and artifact exclusions, so the exact unique total across endpoints is not inferred. No independent paper or trial was promoted in this timeboxed review.
DesignRetrospective cohort validation comparing automated aortic lumen and wall-to-wall segmentation with established ground truth.
Population170 adults with cardiac and/or abdominal aortic CTA, enriched for aortic dilation/aneurysm and/or aortic valve disease; at least half of ground-truth data came from US patients across three US geographic regions.
Scopeexact submission
Tested versionTeraRecon Aorta.CT (1.1.0) configuration described in K243158
Samplen=170
IndependenceSponsor or vendor study
K243158
Final scanner distribution was 77 Siemens, 33 GE, 35 Philips, and 25 Canon. Manufacturer-submitted FDA evidence, not an independent clinical-outcome study.
DesignRetrospective regulatory validation of 22 aortic landmark outputs against ground-truth annotations using vessel identification, distance, and bifurcation-area criteria.
PopulationThe landmarking evaluation began with the 170-study cohort and added 29 supplemental studies because 40-45% of landmarks were outside the field of view or affected by artifacts; annotatable landmarks averaged 73 per target with a minimum of 63.
Scopeexact submission
Tested versionTeraRecon Aorta.CT (1.1.0) configuration described in K243158
IndependenceSponsor or vendor study
K243158
All 22 landmarks passed the stated 80% case-wise criterion and all exact 95% confidence-interval lower bounds were at least 70%. No exact unique total across this context and the segmentation set is inferred.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-07
No public list price or exact contract unit for K243158 was established in the reviewed official sources.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-07
No payer-policy research was applied to this dossier; product-specific coverage or claim eligibility is not established.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
The exact-submission FDA recall query returned no native recall record for K243158. This is not a comprehensive safety clearance and does not exclude family, later-version, or adverse-event information.
Verify security and privacy controls: The reviewed exact packet and official regulatory page do not establish current scoped security controls, encryption, PHI flow, retention, access control, audit, vulnerability management, or incident response for the installed K243158 release.
Verify training: The FDA indication requires trained professionals and understanding of capabilities and limitations, but no exact-version curriculum, competency assessment, or support terms were established.
Verify pricing and total cost: No public list price or exact contract unit for K243158 was established in the reviewed official sources.
Verify reimbursement and coding relevance: No payer-policy research was applied to this dossier; product-specific coverage or claim eligibility is not established.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
24Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The stored PubMed and ClinicalTrials.gov candidate arrays were screened and were empty. No paper or trial was promoted; empty stored arrays do not establish that no external literature or trials exist. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, vendor regulatory page, fda device recall, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history8 sources - 2 history items
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